Illuminated suction apparatus

ABSTRACT

An illuminated suction apparatus including a hand-held surgical device combining a high-performance illumination waveguide with suction. This device would be useful in a wide array of various surgical procedures including open and minimally invasive orthopedics.

RELATED APPLICATIONS

The present application is a continuation of U.S. patent applicationSer. No. 15/789,300 filed Oct. 20, 2017, which is a continuation of U.S.patent application Ser. No. 14/057,933 filed Oct. 18, 2013, which is acontinuation of U.S. patent application Ser. No. 13/619,574 filed Sep.14, 2012 now U.S. Pat. No. 9,636,182, which is a continuation of U.S.patent application Ser. No. 12/616,095, now U.S. Pat. No. 8,292,805,filed on Nov. 10, 2009; the entire contents of which are incorporatedherein by reference.

FIELD OF THE INVENTIONS

The present invention relates generally to the field of surgicalillumination and more specifically to illumination systems withintegrated surgical tools.

BACKGROUND OF THE INVENTIONS

In various surgical procedures, illumination of the surgical field istypically achieved through the use of headlamps and surgicalmicroscopes. There are scenarios in which these illumination sourcesprovide lighting that is either poor in quality or poorly directed. Asan example, during spinal surgery from the lumbar approach, access tothe desired anatomical target area may be achieved through an angledincision on one side of the patient's midline. Light emanating from anoperating microscope is static and may be poorly directed relative tothe angle of surgical access. Conversely, light from a headlamp may beadjusted as a physician tilts or moves his head to redirect the outputbeam, but still may be blocked by various anatomical structures such asthe spinous process or layers of tissue and muscle. Lighting from eithersource may not be adequate as the physician progresses through variousphases of the procedure requiring visualization of the anatomy at varieddepths from the skin-level incision.

Hand-held suction devices are routinely used during surgical proceduressuch as spine surgery. These devices are typically connected to astandard suction source in the operating room, enabling the physician todynamically and efficiently remove blood, bone fragments, or fluidpreviously irrigated into the surgical site. These suction devices aresometimes also used to provide low force retraction of fat, muscle, orother structures during the procedure. The surgeon holds the suctiondevice from its proximal end, manipulating the distal portion of thesuction device during the surgical procedure in order to provide suctionat the desired location. Hand-held suction devices are widely availablein a variety of distal tip configurations suited to various surgicalapplications (Frazier, Poole, Fukijima, etc).

Conventional suction devices have been constructed with fiber opticcable encased in metallic tubing and connected to metallic suctiondevices to provide some level of illumination. These devices facemultiple challenges. These devices have traditionally been manufacturedwith narrow fiber optic assemblies of 2.5 mm or less in diameter. Theseassemblies, with limited cross section, are only capable of transmittingless than 50% of the output light from a standard 5 mm fiber optic cableattached to standard light sources in the operating room. Inefficienciesin the fiber-to-fiber coupling with high intensity light leads to lightlosses at the interface which produces heat. Losses are caused bynon-transmissive zones between the optical fibers and Fresnelreflections at the interface. The spatial zones between the fibers arefrequently the dominant cause of light loss and heat. Excess heat at theinterface can cause thermal damage to the tissues and is also a firehazard in the operating room. Due to the fiber/fiber interface concerns,some manufacturers have produced more expensive devices in which theconnection is eliminated and the entire fiber optic bundle acts as thesurgical light source. Other manufacturers recommend limiting the amountof light that can be transmitted to the operative device and interface.

SUMMARY

The devices described below provide improved illumination in a surgicalsuction device. The illuminated suction device described below includesa metal suction tube having a proximal end and a distal end connected bya central portion. The proximal end of the suction tube is provided withfittings for connection to a vacuum source. The suction tube has aninner surface and an outer surface, with a layer of optical claddinghaving a refractive index between 1.29 and 1.67 on the outer surface ofthe central section of the suction tube, and a illumination waveguidehaving a proximal end and a distal end. The illumination waveguide isformed surrounding the optical cladding on the central portion of thesuction tube, and serves to conduct light around the suction tube fromthe proximal end to the distal end of the illumination waveguide. Theillumination waveguide has a refractive index between 1.46 and 1.7 and anumerical aperture between 0.33 and 0.70. An illumination input isformed into the proximal end of the illumination waveguide forconducting light from a source to the illumination waveguide.

The illuminated suction apparatus includes suction and illuminationfunctions integrated into a hand-held device suited to meet theergonomic needs of the physician. The hand-held, repositionable suctionfunction already prevalently used in surgical procedures is surroundedby an illuminated waveguide which enables the physician to applylighting directly to the desired region of the anatomy below the skinregardless of incision angle, depth, and surrounding anatomicalobstructions. The illumination waveguide is a solid structure designedto specifically guide light from a high-intensity light source and isfabricated using an optical-grade polymer with a specific index ofrefraction such as cyclo-olefin polymer or copolymer or any othersuitable acrylic or plastic. Furthermore, the illumination waveguide canbe engineered to efficiently transmit light from its distal output bysheathing or surrounding it with a second material of lower index ofrefraction properly coordinated to the index of refraction of the corematerial to preserve Total Internal Reflection (TIR). This solid-state,structure guided illumination waveguide is powered via a fiber opticcable connected to a high intensity light source such as 300W xenonsources supplied by Luxtec, BFW, and others.

The illuminated suction apparatus may also include one or more barbs,ridges or other protrusions on the proximal end of the suction lumenenabling the connection of standard PVC surgical tubing or othersuitable vacuum conduit.

The use of a generally solid waveguide for suction illumination, ratherthan optical fibers, eliminates losses due to the non-transmissivespaces between the optical fibers and reduces losses solely to thoseassociated with Fresnel reflections. The marked reduction in lossesassociated with a fiber/fiber junction allows for high intensity lighttransmission to the waveguide without significant heating of theinterface or need for heat sink devices or mechanisms at the interface.With a fiber to waveguide connection, light from a standard 300 wattlight source can be transmitted with use of standard connectors such asACMI, with a steady state temperature below the temperatures harmful tobody tissue without design alteration.

Use of total internal reflection and light mixing in an illuminationwaveguide enables control of the output light profile and enables customillumination profiles. Microstructures can be applied to any suitablesurfaces of the illumination waveguide and light can be extractedincrementally along the walls of the device with injection moldedstructures and other suitable structures at minimal added cost. Use ofsequential extraction surfaces, changes in the numerical aperture of thedevice as a function of position, use of extraction structures—eithermicro or macro structural, with or without changes in the numericalaperture, selective cladding, selective reflective coatings, etc, allcan be used to shape the output profile of the waveguide to meet thedesign specifications or light specifications requested by the user forspecific surgical suction illumination applications.

The device is meant to be disposable, fabricated out of low costmaterials to enable leverage of manufacturing efficiencies through useof processes such as high-volume injection molding, over-molding, andmetal & polymer extrusion. Device assembly would be engineered tominimize labor costs. A low cost, high-performance combination deviceprovides an attractive alternative to existing discrete illumination andsuction devices while minimizing incremental cost to the user.

The illuminated suction apparatus comprises a hand-held surgical devicecombining a high-performance illumination waveguide with suction. Thisdevice would be useful in various surgical procedures including open andminimally invasive orthopedics. The illumination waveguide may also becombined with other surgical devices such as surgical drills and probes,etc.

The surgical suction field must be illuminated by the illuminationwaveguide while the distal suction tip is in active contact with thetissue and or fluid surface. To achieve this effect, the output lightfrom the illumination waveguide must emanate from a point on thewaveguide that is proximal to the distal suction tip of the device. Insurgery, when using a suction illumination device in which the outputlight emanates from a point proximal to the distal end of the device, asurgeon may experience difficulty. When focused on the surgical field,the surgeon uses his/her peripheral vision to watch the suction devicebeing used in the periphery. In spine surgery, the suction devicefrequently is used as a retractor while the surgeon works in thevicinity of the spinal cord. The problem is that while focused on thesurgical field the surgeon uses the central portion of the visual fieldproduced by rods for the high acuity work, the brain misinterprets thelocation of the light source in the periphery of the visual field as thelocation of the distal tip of the suction device. The surgeon may beinclined to plunge the device deeper within the wound. For safety, thesurgeon must frequently shift his eyes from the surgical field to checkon the position of the suction tip.

In an alternate configuration, the distal tip of the suction tube may beconfigured to transmit light or reflect light such that the surgeon seesthe distal tip of the suction as illuminated such that he/she canlocalize the distal tip of the suction device in their peripheral visionwithout directly looking at or focusing on the tip of the device.Extending a thin layer of the waveguide to the tip can provide theeffect. Strategies that implement this effect include but are notlimited to: (a) waveguide extended to the tip with or without surfaceextraction features to cause light to back reflect or scatter off thetip, (b) Use of a thin layer of optically transmissive material withhigh scattering coefficient to cause the suction device to glow (c)reflective surfaces applied to the outside of the central suction device(d) reflective surfaces applied with imperfections on the surface toreflect or scatter the light off the outer surface (e) use of a claddingmaterial applied to the walls of the inner suction tube that transmitsor scatters a portion of the output light, the input to the claddingbeing either an imperfection in the cladding or naturally occurringleakage, (f) fluorescent coating on the tip, (g) phosphorescent coatings(h) use of embedded or graded reflectors along or at the tip of thedevice. Alternatively, the distal tip geometry could be formed tointentionally scatter light (square edges, etc).

One or more surfaces in an optical waveguide sheath or adapters orconnectors may be polarized using any suitable technique such asmicro-optic structure, thin film coating or other. Use of polarizedlight in a surgical environment may provide superior illumination andcoupled with the use of complementary polarized coatings on viewingdevices such as cameras or surgeon's glasses may reduce reflected glareproviding less visual distortion and more accurate color rendering ofthe surgical site. One or more surfaces of an optical waveguide sheathmay also include light filtering elements to emit light of one or morefrequencies that may enhance visualization of specific tissues.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of an illuminated suction apparatus.

FIG. 2 is a cross-section view of the illuminated suction apparatus ofFIG. 1 taken along A-A.

FIG. 3 is a perspective view of an illuminated suction apparatus with ahandle.

FIG. 4 is a cross section view of the distal end of the illuminatedsuction apparatus of FIG. 3 taken along B-B.

FIG. 5 is a cross section view of an illumination conduit inputaccording to the present disclosure.

FIG. 6 is a side view of an alternate illumination conduit.

FIGS. 6A, 6B and 6C are various cross-section views of the alternateillumination conduit of FIG. 6.

FIG. 6D is a perspective view of access port of the alternateillumination conduit of FIG. 6.

FIG. 7 is perspective view of the illumination input of an alternateillumination conduit.

FIG. 8 is perspective view of the illumination input of anotheralternate illumination conduit.

FIG. 9 is a perspective view of an illuminated suction apparatus with ahandle.

FIG. 10 is a cross section view of the illuminated suction apparatus ofFIG. 8 taken along C-C.

FIG. 11 is a cross section view of the handle of the illuminated suctionapparatus of FIG. 10 taken along D-D.

FIG. 12 is a perspective view of an alternate illuminated suctionapparatus.

FIG. 13 is a perspective view of another alternate illuminated suctionapparatus.

DETAILED DESCRIPTION OF THE INVENTIONS

Referring to FIGS. 1 and 2, illuminated suction apparatus 10 includessuction tube 12 made of any suitable material such as aluminum,stainless steel or any suitable acrylic or other polymer. Suction tube12 encloses suction lumen 12L. Illumination waveguide 14 is secured overcladding layer 15 on central portion 12A of suction tube 12 leavinginput or proximal portion 12P and distal portion 12D exposed.Illumination waveguide 14 may have a flat side such as side 14S or side14T to optimize light mixing as light 11L travels from illuminator input14P to output 14D.

Illumination waveguide 14 is made of an optical grade engineeringthermoplastic such as cyclo olefin polymer which efficiently transmitslight. Any other suitable material such as Cyclic Olefin Copolymer,Polycarbonate, Acrylic and or TPC may also be used. The angles and bendsof the waveguide structure are engineered so light transmits through thewaveguide via TIR. The side walls and other features have angles andflat areas such that light is mixed and not allowed to escape until itreaches the distal end of the illuminator and exits with a selecteduniformity. Light that is reflected by TIR is reflected with highefficiency (nearly 100% efficiency). Suction tube 12 introduces aninterface with illumination waveguide 14 that will not be 100%reflective. Thus an uncoated or untreated suction tube will cause asmall portion of light to be lost to absorption and or scattering ateach reflection, ultimately resulting in poor light transmissionefficiency. In order to preserve TIR through the waveguide, claddingmaterial 15 with a specific index is placed between the suction tube andthe waveguide. TIR can also be potentially disrupted by blood or foreignmatter from the surgical site coming into contact with exterior exposedsurface 14X of illumination waveguide 14. Exterior cladding layer 15Xhaving a specific refractive index can also be attached to the outsideof the waveguide. The waveguide material completely surrounds suctiontube 12 in order to provide an illumination pattern from distal end 14Dunobstructed by a shadow from the metallic suction tube. The waveguideand TIR-preserving materials are chosen to provide an optimized lightexit angle, total light output, and illumination suited to properlyvisualize the surgical site. Suction tube 12 could be treated (forexample anodized in the case of aluminum) in order to reduce glare orreflections resulting from interaction with light output from theilluminator.

Referring now to FIG. 3, Light 11L from light source 11 is conducted tothe illumination waveguide using any suitable apparatus such as fiberoptic cable 11C and is then conducted through waveguide 14 and exitsfrom any appropriate structure or structures on or near distal end 14Dof the waveguide. Vacuum from suction source 13 is conducted toilluminated suction apparatus 19 using any suitable suction tube such astube 13T which is connected to vacuum input 21P. The vacuum available atthe distal end of suction tube 12 may be controlled by covering all or aportion of suction hole H in handle 21.

Illuminated suction apparatus 10 may be integrated into a handle such ashandle 21 made of relatively low-cost engineering plastic such as ABS orpolycarbonate. Handle 21 may be formed from two or more components thatcould be separate injection molded components designed to be snap fit,glued, or ultrasonically welded together. Alternatively, the handlecould be formed over an illuminated suction apparatus such as apparatus10 through an over-molding process. The proximal portion of the combineddevice such as illuminated suction apparatus 19 would also contain ahole, hole H, properly positioned to allow the surgeon to enable thesuction function by obstructing all or a portion of the hole with afinger; the hole communicates with the suction pathway in the device,disabling suction by creating a “suction leak” when it is not blocked.Varying the hole geometry, as in the case of Fukijima suction, affordsfiner modulation of the suction function. The proximal end of handle 21may also contain inputs for a traditional fiber optic cable to beattached to illumination waveguide 14, such as a male ACMI connection orother suitable connector, and a vacuum port such as vacuum port 21Pwhich may be a barbed fitting suitable for standard flexible suction PVCsuction tubing of various sizes to be attached. The fiber optic cable isattached to a high-intensity light source such as light 11. Suction tube13T is attached to any standard vacuum source in the OR such as a wastecollection container with integrated vacuum pump such as vacuum source13.

Referring now to FIG. 4, light beam 11B exits waveguide distal face 14Fat a specific angle based on the optical properties such as thenumerical aperture (NA) of the input source, index of refraction of thematerial, and shape of the waveguide. Light pattern cast onto the targetsurgical field is optimized based on the specific distance 16 theilluminator is set back from the distal tip 12D of the suction tube. Fora given light source configuration, divergence angle 18 of light beam11B results in a specific illumination pattern 19 with a total lightoutput and illumination size 17 at any target plane normal to theilluminator such as plane 21. The plane at the distal tip of the suctiontube is of particular interest, since the physician will place thedistal tip at the desired surgical target to enable suction or retracttissue.

Referring now to FIG. 5, light source 11 is transmitting light 11L intocyclo olefin polymer core 30 with refractive index 1.52, fluorinatedethylene propylene (FEP) cladding 32 with refractive index 1.33, and anexternal environment 34 surrounding cladding 32. Light source 11 isassumed to be in air with a refractive index of 1 and a numericalaperture (NA) of 0.55 which corresponds to a half-cone angle, angle 36,of 33.4 degrees. The NA of source 11 is the angle of incidence on thecore when light 11L is coupled in which corresponds to angle 37.Internal light rays 31 initially enter core 30 at the half cone angle of33.4 degrees and are refracted at an angle of 21.2 degrees, internalrefraction angle 39 when they pass into core 30. Internal light 31 thenintersects core-cladding boundary 40 at an angle of 68.8 degrees whichis angle 41. As long as angle 40 is greater than the critical angledetermined by the core and cladding indexes, light 31 will undergo TIRand none of light 31 will be transmitted into the cladding. In this case(n-core=1.52 & n-cladding=1.33) the critical angle is 61.0 degrees.

This ray trace can be worked backwards from the critical angle todetermine the maximum source NA that will still allow for all light toundergo TIR at the core-cladding boundary. If reflection angle 41 is61.0 degrees which corresponds to the critical angle for the selectedcore and cladding, then internal refraction angle 39 is 29 degrees whichmeans that angle 37 must be 47.4 degrees. From 47.4 degrees, the sourceNA is calculated to be 0.74. Therefore, when using the cyclo olefinpolymer/FEP combination, an input source with a much higherNA/Efficiency can be used.

If the source NA is such that all the light coupled into the waveguideundergoes TIR at the core-cladding boundary, then no light ispropagating in the cladding and the environment index does not affectthe waveguide transmission and no light is hitting thecladding-environment boundary. The data in the following table shows howthe critical angle changes at the core-cladding boundary as the claddingindex changes from 1.0 to 1.46 for a cyclo olefin polymer core (n=1.52).This is particularly relevant when designing refractive structures.Knowing the critical angle ahead of time, based on the environment orcladding, the structures can be designed to preferentially leak lightfrom the illumination conduit.

Cladding Index Core-Cladding Critical Angle (degrees) 1.00 41.1 1.1046.4 1.20 52.1 1.30 58.8 1.40 67.1 1.417 68.8 1.42 69.1 1.44 71.3 1.4673.8

When using FEP as a cladding with cyclo olefin polymer, the criticalangle is smaller than the angle from the 0.55NA (68.8 degrees). If nocladding is used, at the index of 1.417 and higher, the critical angleequals to the input angle causing light leakage because TIR is notmaintained. Moreover, the combination of a cyclo olefin polymer corewith FEP cladding allows the use of an input source with NA exceeding0.55. The input source would enable greater light capture from a sourcedue to the larger acceptance angle and provide more light through theillumination conduit assuming constant transmission efficiency.Understanding the critical angles of FEP and open environment,structures can be designed more accurately to extract the light from theillumination conduit.

Any suitable cladding materials such as FEP can be applied to centralportion 12A of suction tube 12 thorough methods such as manual orsemi-automated shrink-application of oversized FEP with a heat gun orfocused heat from a hot-box nozzle, leveraging FEP's characteristicshrink ratio. Any other technique of a cladding such as FEP may be usedsuch as applying a liquid coating of FEP to central portion 12A or anyother suitable surface to be clad. Suction tube 12 with integratedcladding 15 can then have illumination waveguide 14 insert-molded (viaconventional high-volume injection molding) and waveguide 14 will ableto maintain total internal reflection. Use of cladding 15 betweensuction tube 12 and illumination waveguide 14 enables the suction tubeto be formed of any suitable material such as metal or plastic. Thechoice of the plastic material for the suction tube needs to be suchthat the index of that material is below 1.42 for use with a waveguidehaving an index of 1.52 to maintain the differential at the interface ofthe suction tube and the waveguide. However, use of plastic may createchallenges with injection molding processes which require relativelyhigh temperatures and pressures inside of the molding cavity.Alternatively the device can be manufactured such that illuminationwaveguide 14 is formed with an internal lumen with no additional suctionconduit running through it. The challenge posed by this approach is thepotential light transmission efficiency losses stemming from evacuatingbiological material (blood, etc) through the lumen and making contactwith the internal surface of the illumination waveguide lumen throughoutthe procedure.

Cladding with an index of 1.33 shows no light transmission dependence onthe environmental index or the cladding thickness when used with anillumination waveguide having a refractive index at or near 1.52. For acladding with an index of 1.33, the light coupled into the illuminationwaveguide is constrained to the core due to total internal reflection atthe core-cladding interface. Thus, there is no light propagating throughthe cladding, making the cladding-environment boundary condition anegligible factor in transmission. Teflon FEP with an index of 1.33 usedas a cladding material with a cyclo olefin polymer core with index 1.52,shows no dependence on cladding thickness in three representativesimulated surgical environments. Therefore there is no constraint on thecladding thickness of FEP when used with material similar to cycloolefin polymer.

An illumination waveguide formed from material with a refractive indexof 1.46, showed light transmission dependence on both cladding thicknessas well as the external environment. This is a result of introducinglight into the illumination waveguide at an NA of 0.55. Under thiscondition, light enters the core at an angle that is less than thecritical angle of the core-cladding boundary, resulting in lightpropagating into the cladding. Since light propagates through thecladding, the cladding-environment boundary condition (critical angle)is a factor in the light transmission. Due to light propagating throughthe cladding, the cladding thickness also affects the transmission,because as the thickness increases, the rays bounce at the boundariesfewer times as they traverse the length of the waveguide.

Straight waveguide geometry in which the light traversing the structureencounters no bends or radii results in the greatest optical efficiency.However, due to ergonomic constraints or compatibility & management ofessential accessories related to the device such as proximally attachedfiber optic cables and suction tubing, it may be advantageous to designthe proximal light input such that it creates an angle relative to thedistal transmission body of the waveguide structure.

Referring now to FIGS. 6 and 6A, To preserve TIR and maximizetransmission efficiency in illuminated waveguide 51 of suction apparatus50, central portion 52 between light input section 54 and illuminatedwaveguide body 55 should be curved to form angle 53 between the inputand body as close to 180 degrees as possible. Almost any bend or radiusin the tube will cause some light leakage. However, if angle 53 incentral portion 52 is limited to 150 degrees or greater, the lightleakage is very low and the light transmission efficiency is maximized.

The shape of illuminated waveguide 51 morphs or cylindrically “sweeps”or “blends” from a solid cylindrical input, input section 54 into acircular hollow tube of waveguide body 55. Waveguide bore 56 mayaccommodate any suitable surgical tools such as suction tube 58.Suitable surgical tools access waveguide bore 56 through access opening59. As discussed above, light exits waveguide body at or near distal end60 with the majority of light exiting through distal surface 61.

As the cross sectional area of illuminated waveguide 51 increases alongthe light transmission path from section 63 of input section 54 tocentral section 65, to distal cross-section 67 near distal end 60, theNA of the illumination waveguide increases, thus increasing the lightdivergence as light emerges from the distal end of the illuminator. TheNA can also be influenced by bends. It may be possible to counter-bendto adjust the NA. The concepts illustrated above can also bemanufactured as two halves that are over molded around any suitablesurgical tool such as suction tube 58.

Referring now to FIG. 7, disposable illuminated waveguide 70 can besupplied as a stand-alone device. Various suction devices or othersuitable tools such as suction tool 71 can be inserted though centralbore 72, the working channel of the illumination waveguide. A connectioncould be constructed between waveguide 70 and a surgical tool such assuction tool 71 that would allow the waveguide to be secured to varioussuction devices, enabling both waveguide 70 and suction tool 71 to bemanipulated as a single unit. This concept can be applied to otherdevices that would fit through central bore 72 such as drills, etc.Additionally, illuminated surgical apparatus 74 lends itself to dynamicpositioning of the waveguide 70 relative to any surgical tool insertedin central bore 72, such as suction tool 71. For example, the user couldrotate the illuminator about the suction device as in rotation 75, aswell as telescope illuminator along the length of the suction tube alongpath 76, repositioning or expanding or contracting illumination field 77as needed during the procedure.

An alternative approach involves splitting the solid input circle orellipse such as input 78 of FIG. 7 and split input 80 is formed as inFIG. 8 in which half of input light 11L is directed to one half of theinput, arm 82, and the other half of input light 11L is directed to thesecond half of the input, arm 83. Here, arms 82 and 83 come together ina generally rectangular cross-section as input 80 to engage fiber opticcable 11C. However, input 80 can have circular cross-section withsemi-circular arm(s), elliptical or multi faceted for better mixing oflight. The configuration could also have FEP cladding strategicallyapplied to one or more areas of each arm to preserve TIR. To enableproper function of the light extraction features, holes, or othersuitable shapes could be cut into the FEP or other cladding, enabling adesired balance of TIR preservation and suitable light leakage fromspecific zones of the device.

Additional microstructure features can be added to the distal end of anillumination waveguide to optimize control of the illumination patternas well as to homogenize the light output field. Anti-reflectionfeatures, typically diffractive in nature and sub-micron in size, can beadded to the input and output faces of the illuminator to reduce normalFresnel reflection losses. The features of the waveguide, such ascurves, bends, and mounting features, can cause undesired reflections,light leakage, glare, and non-uniform output patterns resulting in poorperformance. Adding microstructure features which may be refractive ordiffractive on or near the distal portion of the illumination waveguidecan potentially provide better light uniformity and or to bias thedivergence or convergence of the illumination pattern as well tohomogenize the light output of the illumination field. Features ortapering of the waveguide can also be added to the outside of anillumination waveguide to control the illumination output. Furthermore,micro lenses such as lens 78L or other micropattern structures can beadded to an illumination waveguide input such as input 78 to bettercontrol the input beam shape or other light input characteristics. Thelight input arm can be round, square or multi faceted to provide abetter mix of the light.

The waveguide can be made in various shapes or cross sections. Currentlypreferred cross-sectional shapes are round, elliptical, or hexagonal.Other cross-sectional shapes such as rectangles, triangles, or squaresare possible. However, generally regular surfaces of the waveguide, aswell as odd number of surfaces may cause a secondary pattern at theoutput. This pattern would manifest as bright and dark spots. Crosssections resembling even numbered higher order polygons such as thehexagon are currently preferred. As the number of faces in thecross-section increase, these cross sections would approach a circle,such a device design would potentially complicate manufacturingprocessing (such as injection molding), thereby increasing costs.

The illuminator can be tapered to increase or decrease its cross sectionas light travels from the input to extraction zones. Tapering biases theNA, causing either a tighter output spot (for increased area at theexit) or a larger more diffuse spot (decreased exit surface area,breaking TIR).

For an illuminated suction device, in many surgical applications, thereis a need for circumferential illumination around the device. Theillumination may need to be uniformly circumferential or delivered in anoff axis orientation for most of the lighting to orient anterior to theretractor.

Referring now to FIGS. 9 and 10, handle 93 of illuminated suction device90 can be used to preserve TIR within illumination waveguide 94 throughcreation of air gap 91 (n=1.0) around waveguide 94. The design of thehandle structure could include a portion that partially or fully coversthe length of waveguide 94 to create the desired air gap. Features suchas standoffs 93X can be molded into the surface of the handle in contactwith the illuminator to create a gap between components. A similarconfiguration may be formed between suction tube 92 and illuminatedwaveguide 94, air gap 95 can be formed without standoffs based on thedesign tolerance between the ID of the illuminator and OD of the suctiontube or with one or more standoffs such as standoff 92X or standoff 94Xor any suitable combination.

The light output from illuminated waveguide 94 can be dynamicallyfocused by permitting all or a portion of distal casing 96 to slidealong axis 97 over the illuminator. The user can slide the tube downover the illuminated waveguide 94 to reduce the divergence angle and“focus” light 99L.

Referring now to FIG. 11, the design of handle 93 must accommodate asuitable routing and termination of the suction channel and solid-stateilluminator such that a suction flow control hole H is presented to theuser in an ergonomically favorable position. Based on the way a user isexpected to hold and manipulate an illuminated suction apparatus and theflow pattern of evacuated material from the patient, hole H may bepresent at or near the top surface 98 of the proximal handle. This canaccomplished by forming handle 93 with at least two parts such as topsection 93T and bottom section 93B. In addition to providing a shieldfor and proximal terminus for the illuminated waveguide 94, top handleportion 93T also contains suction flow control hole H. The top andbottom handle portions are sealed, with the bottom portion 93B creatinga chamber in communication with proximal termination 92P of suction tube92. Evacuated debris can be kept from flowing through to vacuum tubeconduit 93P and out of hole H based on the geometry of the chamber 100and pathway to flow control hole H. Alternatively a “strainer” or“filter” such as filter 102 may be included in handle 93 to capture anysolid or liquid debris and prevent the debris from making their way outthrough hole H. Features in handle 93 could also allow the user todisassemble the top and bottom portions to clear any collected debris.

While the concepts presented thus far focus on a completely disposablenon-modular device, alternative architectures are possible including thefollowing:

-   -   a. Disposable suction tips (varying French sizes & styles such        as yankaeur, etc.) that integrate with a disposable device        through a “quick-connect” attach & detach scheme.    -   b. Disposable illumination sheaths such as waveguide sheath 16        may accommodate any suitable surgical instrument such as for        example, a drill, burr or endoscope 18 which is encased,        enclosed or otherwise surrounded by optical waveguide sheath 16.        Illumination sheaths can be various materials such as flexible        silicone.    -   c. Disposable distal suction tips or other implements (nerve        probes, etc) can also be integrated with a reusable proximal        illuminator containing a traditional fiber optic bundle. This        would enable rapid tip style exchange without the need to unplug        cables. This approach also provides a means of unclogging        trapped evacuated material.    -   d. Reusable proximal handles with removable single use        illuminators/suction tubes. Enables easy change—out of devices        without need to unplug cables.

Referring now to FIG. 12, suction lumen 108 may be formed in suctionelement 109 that may be formed around an illuminator such as waveguide110, as shown in illuminated suction apparatus 111. This configurationwould allow for output light 112 to exit from a cylindrical source suchas waveguide 110 without the shadowing caused by having a centralillumination tube coaxial to the illuminator.

The routing of the suction conduit through the illuminator can be variedto optimize the illumination output and balance ergonomicconsiderations.

Referring now to FIG. 13, illuminated suction apparatus 116 isconfigured to enable suction tube 118 to be strategically routed throughillumination waveguide 120 at angle 121 such that (1) proximal exposedend 118P is at the top of the device where the suction control functioncan be more readily accessed by the user (2) distal end 118D of thesuction tube emerges from the bottom of the device below illuminationoutput 122, providing optimized lighting of the surgical site from abovethe suction tube. In this configuration the suction tube changes lighttransmission paths through the illumination waveguide by introducingreflective surfaces which more thoroughly mix the light. It is possibleto maintain the efficiency by using high reflective coatings, air gapsand cladding such as cladding 123. However, the added reflectancesurfaces of the suction tube may cause the NA to increase.

Rotationally symmetric illuminated suction devices such as illuminatedsuction apparatus 116 may produce circumferential, uniform light outputwith strategic positioning of the suction tube that mitigates shadowingfrom the suction tube protruding from the distal surface of thewaveguide. Light traversing the illuminated waveguide may havechallenges with secondary reflectance surfaces, thus widening the lightoutput pattern. Illuminated suction apparatus 116 is also expected tohave a very large NA.

Illumination waveguides such as waveguides 14, 51, 70, 94, 110 and 120may also be made malleable out of material like silicone. This can beuseful to “pull over” an instrument like suction tube 12. Theillumination waveguide can be made of a malleable material such assilicone allowing it to be pulled over a rigid suction tube, potentiallylowering cost. Alternatively the malleable illumination waveguidematerial can be formed over a deformable suction tube structure, or adeformable structure that contains selective strength members (beams,etc). This would enable dynamic shaping of the suction tube to variousdesired shapes suited to the clinical application.

The illumination waveguide can be fabricated with materials of varyingindices in a “stacked” or “composite” structure to shape and control thelight output.

An alternative approach involves splitting an illumination waveguidewith a solid light input with a circular or elliptical cross-section,routing and re-combining the waveguide into the original startinggeometry. An illumination waveguide can then be molded over an internalsuction tube. Alternatively, the suction tube in this configurationcould run alongside the spit illuminator geometry.

If the cross section area is maintained (that is, distal and proximalends on either side of split have same cross section, the intermediateshape of the waveguide can be manipulated. In the configuration listedabove, there should be no significant loss of efficiency or change inNA. Thus, the input and output light patterns should be very similar inshape and intensity.

Thus, while the preferred embodiments of the devices and methods havebeen described in reference to the environment in which they weredeveloped, they are merely illustrative of the principles of theinventions. Other embodiments and configurations may be devised withoutdeparting from the spirit of the inventions and the scope of theappended claims.

We claim:
 1. A surgical device, comprising: a suction tube having aproximal end, a distal end, and a central portion extending between theproximal end and the distal end; an inner optical cladding surroundingthe suction tube; an optical waveguide coupled to the suction tube withthe inner optical cladding between the optical waveguide and the suctiontube, wherein the optical waveguide has a proximal portion and a distalportion, wherein the optical waveguide is configured to transmit lightfrom the proximal portion to the distal portion by total internalreflection; and an outer optical cladding coupled to the opticalwaveguide, wherein the outer optical cladding surrounds the opticalwaveguide, the inner optical cladding, and the suction tube, wherein adistal portion of the suction tube extends distally from a distalmostend of the inner optical cladding, a distalmost end of the outer opticalcladding, and a distalmost end of the optical waveguide.
 2. The surgicaldevice of claim 1, wherein a proximal portion of the suction tube and aproximal portion of the optical waveguide are disposed within a commonhandle.
 3. The surgical device of claim 1, wherein the inner opticalcladding and the outer optical cladding have respective indices ofrefraction that are each lower than an index of refraction of theoptical waveguide.
 4. The surgical device of claim 1, wherein therespective index of refraction of the inner optical cladding is between1.29 and 1.67.
 5. The surgical device of claim 4, wherein the index ofrefraction of the optical waveguide is between 1.46 and 1.7.
 6. Thesurgical device of claim 1, wherein the optical waveguide comprises abend that defines an angle between a proximal portion of the opticalwaveguide and a distal portion of the optical waveguide.
 7. The surgicaldevice of claim 6, wherein the angle is greater than 150 degrees.
 8. Thesurgical device of claim 1, wherein a cross-sectional shape of theoptical waveguide transitions from a solid cylinder shape to a crescentshape.
 9. The surgical device of claim 1, wherein a cross-sectional areaof the optical waveguide increases in a direction from the proximal endof the optical waveguide to the distal end of the optical waveguide. 10.The surgical device of claim 1, further comprising a fiber optic cablecoupled to the proximal end of the optical waveguide.
 11. The surgicaldevice of claim 1, further comprising a plurality of standoffs betweenthe optical waveguide and the suction tube, wherein the plurality ofstandoffs inhibit engagement between a portion of the suction tube and aportion of the optical waveguide to thereby define an air gap betweenthe portion of the suction tube and the portion of the opticalwaveguide.
 12. The surgical device of claim 1, wherein the suction tubeis formed from a metal.
 13. A method of forming a surgical device,comprising: providing a suction tube having a proximal end, a distalend, and a central portion extending between the proximal end and thedistal end; coupling an inner optical cladding to the suction tube suchthat the inner optical cladding surrounds the central portion of thesuction tube; coupling an optical waveguide to the suction tube with theinner optical cladding between the optical waveguide and the suctiontube, wherein the optical waveguide has a proximal portion and a distalportion, wherein the optical waveguide is configured to transmit lightfrom the proximal portion to the distal portion by total internalreflection; and coupling an outer optical cladding to the opticalwaveguide, wherein the outer optical cladding surrounds the opticalwaveguide, the inner optical cladding, and the suction tube, wherein adistal portion of the suction tube extends distally from a distalmostend of the inner optical cladding, a distalmost end of the outer opticalcladding, and a distalmost end of the optical waveguide.
 14. The methodof claim 13, further comprising forming the optical waveguide with across-sectional shape that transitions from a solid cylinder shape to acrescent shape.
 15. The method of claim 13, further comprising formingthe optical waveguide with a cross-sectional area that increases in adirection from the proximal end of the optical waveguide to the distalend of the optical waveguide.
 16. The method of claim 13, furthercomprising forming the optical waveguide with a bend that defines anangle between a proximal portion of the optical waveguide and a distalportion of the optical waveguide.
 17. The method of claim 16, whereinthe angle is greater than 150 degrees.
 18. The method of claim 13,wherein coupling the inner optical cladding to the suction tubecomprises: fitting a shrink wrap tube over the central portion of thesuction tube; and heating the shrink wrap tube to shrink the shrink wraptube onto the suction tube.
 19. The method of claim 13, furthercomprising forming a handle having a first input for coupling theoptical waveguide to a light source and as second input for coupling thesuction tube to a suction source.
 20. The method of claim 13, whereinthe suction tube is formed from a metal.